A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;

History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;

History of alcoholism or drug addiction within 1 year prior to drug administration;

Tobacco or nicotine use within 6 months prior to study start;

Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;

Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;

Inability or unwillingness to swallow capsules;

Participation in a drug study in which a drug was administered within 30 days prior to study start;

Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;